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Regulatory Practices

Customer Support , preparation and sending:

  • Submissions and follow-up until the conclusion of national and European procedures;
  • Variations (including definition of the type and sharing of the regulatory strategy);
  • CESP Submissions;
  • Renewals;
  • Renewals;Transfers of MA ownership, Deletion on Marketing (DoMa)
  • Prices and negotiation with IT Health Authority AIFA;
  • Publication on the Official Gazette;
  • Submission of promotional material, sponsorships;
  • Regulatory and promotional activities related to parapharmaceutical products and medical devices.

Product Information (PIL, LABEL, SmPC)

  • Texts Translations, preparations, maintenance, modifications and updates;
  • QRD adjustments;
  • RUT (Readability User Test);
  • Translations from and into Italian from different languages (TUV certificate);
  • Pharmaceutical printed materials

e-Reg is a complete and up-to-date support system for managing every regulatory aspect,

with constant control over data, deadlines, and documentation.

e-Reg

Regulatory Desk: Online procedures, documents, data, and information in one click

OP Pharma, by integrating its consultancy and regulatory management services, offers its clients the possibility to consult online data and the electronic archive of documentation related to their product portfolio through e-Reg, a customized web platform that allows rapid access to information and documentation and provides an overall view of all products in every single aspect.
The client will have access to the following sections:

Single
Regulatory status of each product/package (documents, texts, variations, prices, manufacturing site data, APIs)
Overall
An overall view and data analysis (registration accountability, variations, additional monitoring, doping, transparency list)
Deadlines
Renewal deadlines, variations, personalized mailing
Task progress
Regulatory requirements (QRD Template, AIFA Alerts)
Filters
Product/package, Class, API, Manufacturing Site, Pending Variations
Access
e-Reg is accessible from any browser without any installation. There is no limit on the number of users or expiration date for document availability.
System security
The system is protected by antivirus, firewall, and weekly backups. Access is restricted to accredited client IP addresses, and backup copies are provided to the client via FTP.